One of the greatest challenges a Biomedical Engineer can undertake is building a diagnostic startup company from scratch. It is truly an interdisciplinary undertaking using not only a wide variety of technical skills, but also full contact with the worlds of business, marketing, and administration. It requires an unwavering commitment to try, fail, and learn anything that is needed to try again. The challenge is to create a new organization starting from nothing but an idea and a maybe a few very dedicated people including yourself.

I will tell my own story of what it is like to start a medical diagnostic startup (Sandstone Diagnostics). This story will touch on the following points:

– Developing a “high potential” invention at Sandia National Laboratories

– Founding a company

– Building an R+D lab in a garage

– Raising money

– Hiring and leading a team

– Translating a prototype into something that can be built en masse

– Interacting with the FDA and running clinical trials

I will also talk a bit about the home use Trak Male Fertility Kit that my company is currently taking through clinical trials. Almost half of infertility cases are attributable to the male partner, and I will show what Sandstone Diagnostics is doing to make a difference.